ComplianceOnline

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

Instructor: Karl M. Nobert
Product ID: 703313
  • Duration: 90 Min

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This webinar will focus on the different types of import alerts issued by the FDA. It will provide the attendees strategic recommendations for removing one’s company and/or products from an import alert.

Why Should You Attend:

An import alert allows the FDA to detain, without physical examination, products that either have or potentially could violate the Food, Drug, and Cosmetic Act (“FDC Act”). Import alerts lets FDA field staff knows that the agency has enough evidence or other information to refuse admission of future shipments of an imported article. There are a variety of factors that could lead the FDA to place a product, manufacturer, shipper, grower, geographical area, and/or country on import alert.

This webinar will provide attendees with background about FDA import alerts, examine why there are issues, where to locate them, how to find out whether a company or product is the subject of an import alert, and finally, provide a series of strategic recommendations for removing a company or product from an alert.

Learning objectives:

  • Understand the nature of import alerts: What are they? What purpose do they serve? What do they mean for a company?
  • Become familiar with CBP and FDA’s shared jurisdiction at U.S. ports.
  • Understand company or products to be added to an import alert.
  • Be able to find and search FDA’s database of import alerts.
  • Understand the potential and real impact of being named on an FDA import alert.
  • Be able to identify the steps for removing a company or product from an import alert.
  • Know what to do if you learn that your products are being detained by FDA at a port and your company’s name is added to an import alert.

Areas Covered in the Webinar:

  • Import alerts
  • The different types of import alert issued by FDA
  • What causes a country, company or products to be added to an import alert
  • What impact does being named on an import alert have on a company
  • What to do if your products are held or detained at the port by FDA
  • What to do if your company or products are named on an import alert
  • Strategic recommendations for removing one’s company and/or products from an import alert

Who Will Benefit:

This webinar will be beneficial for the individuals in pharmaceutical, biologics, animal health, food, medical device and other biotech companies. Following personnel will benefit:

  • Regulatory Affairs
  • Managers
  • Consultants
  • Scientists
  • Research Analysts
  • State Policy Officials
  • Insurers focusing on Representations & Warranties Insurance
  • Investment Analysts
  • Venture Capitalists
  • Labelers
  • Product Distributors
  • Importers, Customs Brokers
  • Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a Food & Drug Regulatory Attorney and a Principal with The Nobert Group which focuses on FDA and USDA legal issues. He provides regulatory advice and counseling to both domestic and international food and feed companies. Among others, his clients include ingredient manufacturers, formulators, labelers, distributors and exporters of various animal health products. He also has considerable experience related to the regulation of veterinary biologics including veterinary cellular and genetic therapies.

Topic Background:

An Import Alert allows FDA to detain, without physical examination, products that either have or potentially could violate the Food, Drug, and Cosmetic Act (“FDC Act”). Once a shipment is refused admission to the U.S., the importer has an opportunity to introduce evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held at a warehouse or at the importer’s premises and cannot be distributed. If the shipment is not proven to be safe, it must be destroyed or exported within 90 days.

The alert can be issued for an import from a manufacturer, shipper, grower, geographical area, or country. If the problem or condition exists on a wide scale, federal inspectors would be instructed to detain all products of a certain kind coming from that country. An imported product, firm, region, or country may remain in this status until evidence or other information is provided that gives FDA confidence that the shipment is safe for consumers and that future shipment will be in compliance with the law. The conditions that the importer has to meet vary depending on the stipulations in the import alert.

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